Tack device

ABSTRACT

A method of preparing a sling combination is described. The method comprises the steps of providing a sling formed of a biocompatible material and having a body comprising two ends; mounting the sling on a first tack at a first end of the body of the sling; and mounting the first stack on a tacking device.

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for treatingincontinence, especially by bladder neck support.

BACKGROUND OF THE INVENTION

Urinary incontinence is an unfortunately common medical complaint. Manytreatments have been suggested. Recently, a relatively minimallyinvasive technique has become more common, in which a bladder neckand/or urethra is supported by a sling, so that the urethra is partiallycompressed and/or has a support below it so that during straining and/orbladder/uretheral descent, pressure is applied between the urethra andthe sling, thereby closing its lumen.

Benderev et. al, in U.S. Pat. No. 5,836,314 and Brenneman et al, in PCTpublication WO 98/19606, the disclosures of which are incorporatedherein by reference, describe exemplary procedures for treatingincontinence. Two or more bone anchors are attached to the pubic bone.Each anchor is pre-threaded with a suture. Brenneman suggests attachinga sling to the sutures such that when the sutures are pulled tight andknotted, the sling is urged towards the pubic bone. Benderev suggestsintegrally molding one end of a suture with a “suture support”, whichsuture support is provided to prevent damage to the urethra by thesutures.

It should be noted that, prior to the introduction of slings, someearlier procedures, for example the Burch procedure and the M.M.K.procedure, used only sutures without a sling to support the bladderneck. Also the, different, needle bladder neck suspension procedure usesonly sutures. The disadvantage of these procedures is that the baresutures can cut into and damage the urethra. In a sling procedure,described below, a mesh or a wide strip of material contacts the urethrainstead of sutures, so that the urethra is not damaged.

FIG. 1 is a schematic side cut-through illustration of a pubic region 20during such a procedure, before the sutures are tightened. In thefigure, a sling 32 is located between a vagina 22 and a bladder neck 26of a bladder 24. The sling is threaded by a plurality of sutures 36,which are attached to a bone anchor 30, in a pubic bone 28.

There are two commonly applied methods of bringing sling 32 to aposition between vagina 22 and bladder neck 26. In a first method, anincision is made in the vagina, at an area corresponding to that markedwith reference number 34, perpendicular to the figure plane, therebyforming a flap. The sling is inserted into the incision, under the flap,and after the sling is tightened, the incision is closed. In a secondmethod, only a small hole in the vagina lining is made for each insertedbone anchor and a tunnel is formed between the two holes, for insertionof sling 32 therethrough.

This family of suture-sling techniques has several disadvantages:

(a) the suture is an additional element which may be damaged during theprocedure or after it;

(b) knotting the sutures (after they are tightened) takes skill andtime; additionally, some patients have complained that the sutures causediscomfort during sexual activity, since such sutures typically havesharp edges and are often bulky as the suture may have to be knotted asmany as six times to assure patency;

(c) the sutures add some unwanted leeway between the positioning of theanchors and the positioning of the ends of the sling; and

(d) the sutures may damage the sling by cutting through it (older tissuebeing more susceptible); if the suture enters the sling at multiplepoints (to reduce strain at the sling-suture joints) the sling may bedeformed by the sutures.

U.S. Pat. No. 3,580,313, to McKnight, the disclosure of which isincorporated herein by reference, suggests using the tissue between theurethra and the vagina as a “sling” and stapling that tissue to thepubic bone. However, this solution may not be suitable for somepatients, such as older patients, as their tissue are usually too weakto provide a suitable support. Also, older tissue is more susceptible tocut-through damage from the staples.

SUMMARY OF THE INVENTION

An aspect of some preferred embodiments of the present invention relatesto a sutureless method of supporting a bladder neck. In a preferredembodiment of the invention, the bladder neck is supported by a sling,and the sling is directly tacked to a pubic bone, without intermediatesutures. Alternatively or additionally, the sling is directly attachedto the bone using other means, for example an adhesive. As used herein“directly attached” means attached without an intermediate suture. Inmany cases, the sling will not be in direct physical contact with thebone. Generally, but not necessarily, there will be only tissue (if any)between the sling and the bone. However, in a preferred embodiment ofthe invention, there will not be a suture or other implant between thesling and the bone.

It is noted that by not requiring sutures, the previously required stepof tightening and tying the sutures is not required.

An aspect of some preferred embodiments of the invention relates to asling that is preloaded with one or more tacks at one or both endsthereof prior to insertion into a body. In a preferred embodiment of theinvention, the pre-loaded sling is mounted on a tacker, for insertioninto the body. Alternatively, the sling is not provided as pre-mountedon a tack and is mounted on a tack only after the tack is mounted on atacker with a protruding tack. Optionally, the mounting of the sling isa two step process, in which the tack is assembled after the sling ismounted on it.

An aspect of some preferred embodiments of the invention relates totacks with wide heads. In a preferred embodiment of the invention, atack comprises a shaft and a head, where the head has a maximum extentperpendicular to the shaft, which extent (the width of the head) isconsiderably greater the shaft diameter. Alternatively or additionally,the width of the head is made considerably greater than a maximum extentof a bone-entering portion of the tack (which is usually wider than theshaft). Thus, the head is larger than the hole formed in the sling byits being tacked and the head can maintain the sling in place. In apreferred embodiment of the invention, the head is substantiallycircular or polygonal. Alternatively, the head is a bar-shaped beamwhich is perpendicular to the shaft. As used herein “considerablylarger” means 50%, 100%, 200%, 400% larger or more. Although the headmay be large, it is not necessarily solid. Rather, one or more holes maybe formed in the head. Optionally, these holes are used for threadingthe sling through them.

In some preferred embodiments of the invention the head can rotaterelative to the shaft.

An aspect of some preferred embodiments of the invention relates todisassembled or deformable tacks, in which a sling may be pierced with asmall diameter portion of the tack. The tack is then assembled ordeformed, so that the head and/or bone entering portions of the tackhave a larger diameter than the piercing portion. In one example, thetack comprises two parts, a head with a shaft portion and abone-entering portion. The sling is pierced by the shaft portion andthen the bone-entering portion is attached to a protruding end of thetack. In another embodiment, the bone-entering portion is maintained ata small diameter until after it pierces the sling, for example by a finin the shaft receding into a recess formed in the shaft or by the shaftbeing expandable. In another example, the head is separate from theshaft.

An aspect of some preferred embodiments of the invention relates to anattachment to a bone stapler, which attachment holds a sling in placeover a staple-exit portion of the stapler, to enable a standard stapleror a standard bone-anchor inserter to be used for tacking slings inaccordance with a preferred embodiment of the invention. In a preferredembodiment of the invention, the type of stapler provided is such thatthe tip of the staple does not protrude from the stapler, so the slingis preferably maintained in place solely by the attachment. In analternative embodiment, the tip of the staple does protrude from thestapler and may serve to at least partially hold the sling, while theattachment fixes the orientation of the sling relative to the staple orthe attachment. If a two prong staple (or tack) is used, such anattachment may serve solely to keep the sling from slipping off the tipof the staple.

An aspect, of some preferred embodiments of the invention, relates to atacker which includes two stapling heads, for simultaneous tacking oftwo sides of a sling. In a preferred embodiment of the invention, thetacker comprises two arms, with a tacking head at the end of each arm.Preferably the angle between the arms is controllable to adapt thetacker for different length slings. In a preferred embodiment of theinvention, the sling is pre-mounted on the two heads prior to insertioninto the body.

There is thus provided in accordance with a preferred embodiment of theinvention, a surgical tack, comprising:

a single shaft formed of a bio-compatible material and having a tipadapted for entering and engaging bone; and

a head mounted on said shaft, said head adapted for engaging a substratebetween said head and said bone. Preferably, said shaft is a separateelement from said head. Preferably, said head is rotatable relative tosaid shaft. Alternatively or additionally, said head is mounted in aslot defined at an end of said shaft. Alternatively or additionally,said head is mounted on a narrowing of said shaft.

In a preferred embodiment of the invention, said head comprises only onearm extending substantially perpendicular to said shaft.

In a preferred embodiment of the invention, said head comprises at leasttwo arms extending substantially perpendicular to said shaft.Alternatively, said head comprises at least one arm extending at anangle to said shaft.

In a preferred embodiment of the invention, said head defines aplurality of apertures therethrough. Alternatively or additionally, saidhead comprises a plurality of protrusions extending in a direction ofsaid tip, which protrusions are adapted for engaging said substrate.Preferably, said protrusions are smooth at a portion thereof where theyengage said substrate. Alternatively, said protrusions are pointed at aportion thereof where they engage said substrate.

In a preferred embodiment of the invention, said protrusions extend atleast half a thickness of the substrate.

In a preferred embodiment of the invention, the tack comprises at leastone fin extending from said shaft, distal from said head, and adaptedfor engaging said bone after insertion of said shaft into said bone.Preferably, said at least one fin comprises at least two angularlyspaced apart fins. Alternatively or additionally, said at least one fincomprises at least two axially spaced apart fins. Alternatively oradditionally, said at least one fin comprises a separate element fromsaid shaft. Alternatively, said at least one fin is integrally formedwith said shaft.

In a preferred embodiment of the invention, said shaft defines a recessand said at least one fin is adapted for recessing into said definedrecess, when force having a vector perpendicular to said shaft isapplied to said fin.

In a preferred embodiment of the invention, said at least one fin ismounted on a separate fin element, which is attached to said shaft.

In a preferred embodiment of the invention, said head is roughened at aportion thereof that engages said substrate.

In a preferred embodiment of the invention, said tack comprises anadvance-stop on said shaft adjacent said head and separate from saidhead, such that said advance-stop prevents said head, at portions nearsaid shaft, from touching said bone. Alternatively or additionally, saidhead has two configurations, one in which it has an substantially largetransaxial extent and one in which it has a substantially smalltransaxial extent.

There is also provided in accordance with a preferred embodiment of theinvention, a tack insertion device, comprising:

a “C” shaped body;

a handle at one end of said body;

a slotted tack holder at a second end of said body, wherein said slottedtack holder holds a tack pointed towards said handle and wherein saidslot is adapted for frictionally engaging a tack.

Preferably, said slotted head is adapted to engage a tack having amulti-arm head. Alternatively or additionally, said slotted head isadapted to engage a tack having an apertured head.

In a preferred embodiment of the invention, said device comprises asecond tack holder attached to said body at an offset from said firsttack holder. Preferably, said device comprises a selectable offsettingmechanism for setting said offset.

In a preferred embodiment of the invention, said device comprises asafety release mechanism that prevents the release of said tack.

There is also provided in accordance with a preferred embodiment of theinvention, a method of preparing a sling combination, comprising:

providing a sling formed of a biocompatible material and having twoends;

mounting said sling on a first tack at a first end of the sling; and

mounting said first tack on a tacking device. Preferably, said methodcomprises mounting said sling on a second tack at a second end of saidsling. Preferably, said method comprises mounting said second tack onsaid tacking device.

In a preferred embodiment of the invention, said method comprisesadjusting an offset between two tacking heads of said tacking device.

In a preferred embodiments of the invention, said method comprisescutting said sling after mounting said first tack on said sling.

In a preferred embodiment of the invention, mounting said sling on saidfirst tack is performed after said tack is mounted on said tackingdevice. Alternatively, mounting said sling on said first tack isperformed before said tack is mounted on said tacking device.

In a preferred embodiment of the invention, the method comprisesassembling said first tack after mounting said sling on said first tack.Alternatively, the method comprises assembling said first tack aftermounting said first tack on said tacking device.

Preferably, assembling said first tack comprises attaching a head to ashaft of said tack. Alternatively or additionally, assembling said firsttack comprises attaching at least one fin to a shaft of said tack.

In a preferred embodiment of the invention, mounting said sling on saidtack comprises piercing said sling by said tack. Alternatively, mountingsaid sling on said tack comprises inserting said tack into a hole insaid sling.

In a preferred embodiment of the invention, the method comprisesinserting at least a part of said tacking device into a human vagina,after mounting said tack on the tacking device.

There is also provided in accordance with a preferred embodiment of theinvention, a kit, comprising:

a sling having a length suitable for bladder neck supporting; and

at least one tack, having a head and a shaft, wherein said head has anextent perpendicular to the shaft, which extent is substantially greaterthan a diameter of the shaft. Preferably, said sling contains at leastone pre-punched aperture. Alternatively or additionally, said slingcontains at least two adjacent pre-punched apertures, for setting aneffective sling size.

In a preferred embodiment of the invention, said at least one tackcomprises at least two tacks. Alternatively or additionally, said slingis reinforced at least at its ends.

There is also provided in accordance with a preferred embodiment of theinvention, a kit, comprising:

a sling formed of bio-compatible material and having a length andmechanical properties suitable for bladder neck supporting; and

a clip adapted to hold said sling against a tacking head of at least aparticular tacking or stapling device.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more clearly understood from the followingdetailed description of the preferred embodiments of the invention andfrom the attached drawings, in which:

FIG. 1 is a schematic cut-through illustration of a pubic area during aprior art bladder neck support operation;

FIG. 2 is a schematic cut-through illustration of a pubic area during abladder neck support operation, in accordance with a preferredembodiment of the invention;

FIG. 3 is a schematic illustration of a tack for attaching a sling to abone, in accordance with a preferred embodiment of the invention;

FIG. 4 is a schematic illustration of a two part tack for attaching asling to a bone, in accordance with a preferred embodiment of theinvention;

FIG. 5 is a schematic illustration of a tacker for attaching the tack ofFIG. 3;

FIG. 6 is a blow-up of a tacking head part of the tacker of FIG. 5;

FIG. 7 illustrates a tack which is preloaded on a sling and mounted on atacker, in accordance with a preferred embodiment of the invention;

FIG. 8 is a schematic illustration of a two-headed tacker, in accordancewith a preferred embodiment of the invention;

FIGS. 9A-9D illustrate an alternative tack, in accordance with apreferred embodiment of the invention;

FIG. 10, which corresponds to FIG. 6, illustrates the mounting of thetack of FIGS. 9A-9D on a tacker;

FIGS. 11A-11B illustrate a variation of the tack of FIGS. 9A-9D, inaccordance with a preferred embodiment of the invention;

FIGS. 12A-12C illustrate variations of the head of a tack, in accordancewith alternative preferred embodiments of the invention;

FIGS. 13A and 13B illustrate a recessed fin tack, in accordance with apreferred embodiment of the invention;

FIGS. 13C and 13D illustrate an expanding head tack, in accordance witha preferred embodiment of the invention; and

FIG. 14 is a schematic illustration of a sling grasping attachment for astapler, in accordance with a preferred embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 2 is a schematic cut-through illustration of a pubic area during abladder neck support operation, in accordance with a preferredembodiment of the invention. A sling 40 is shown as being tackeddirectly to pubic bone 28, by a tack 42 and being held in place by ahead 44 of tack 42. In a preferred embodiment of the invention, a shaftof tack 42 pierces sling 40. Alternatively or additionally, the sling isheld against the bone by friction, caused by head 44 urging sling 40against pubic bone 28 (possibly through intervening tissue).

In a preferred embodiment of the invention, the following method is usedto attach the sling to the bone:

(a) a first tack is tacked (preferably through sling 40) into a firstlocation on pubic bone 28;

(b) the sling is inserted between vagina 22 and bladder neck 26 or theurethra: access is preferably via one or more incisions in the vaginalwall;

(c) a second tack is tacked through the sling and into a second locationon the pubic bone; and

(d) any incisions in the vagina are preferably closed, e.g., sewn up.

The above method may be varied in accordance with various preferredembodiments of the invention. In particular, the order of steps may bechanged and steps may be combined. In one example, the two tacks may betacked simultaneously, using a two-headed tacker, as described forexample with reference to FIG. 8.

In a preferred embodiment of the invention, the sling comprises a stripof xenograft material. Alternatively or additionally, the slingcomprises human cadaver tissue or auto-graft material harvested from thepatient. Alternatively or additionally, the sling comprises a syntheticmaterial, for example Dacron mesh. In a preferred embodiment of theinvention, the sling is about 1 mm thick, 1-2 cm wide and 5.5 cm long,between the tacked points. It should be appreciated however, that theexact dimensions of the sling may vary responsive to the anatomy of thepatient being treated. Possibly, a prior-art sling may be utilized.

In a preferred embodiment of the invention, the sling is reinforced ator near portions thereof through which the tack is inserted and/orportions of the sling engaged by head 44. Alternatively, the sling isnot reinforced. Alternatively or additionally, a hole is pre-punched inthe sling at or near where the insertion point of the tack. Possibly,the hole is reinforced. The hole may have a shape similar to thecross-section of the shaft or it may be larger or smaller than thecross-section and/or of a different shape. In a preferred embodiment ofthe invention, one or more slits are formed (and optionally reinforced)in the sling at locations where the tack is to be inserted instead of—orin addition to—punching a hole thereat. Alternatively or additionally,an elliptical or a long rectangular slot may be cut in the strip toaccommodate a plurality of tack positions. Alternatively oradditionally, a plurality of pre-punched holes and/or pre-cut slitsmaybe provided for that purpose. Excess sling length is optionallyremoved either prior to or after deployment of the sling. Alternativelyor additionally, the sling is formed of two parts, that are gluedtogether to form a sling of a desired length, prior to or after beingtacked to the bone.

In a preferred embodiment of the invention, human cadaver based slingsdo not have pre-provided holes, while synthetic slings do. In somecases, holes are cut just prior to the procedure. Alternatively, theholes are cut in a factory.

In a preferred embodiment of the invention, the sling has a smoothsurface. Additionally or alternatively, at least one of the two surfacesof the sling is rough, for example to promote tissue ingrowth.Additionally or alternatively, the sling is coated with tissue growthenhancing or retarding coatings, possibly both, on different parts ofthe sling. Additionally or alternatively, the sling may have a pluralityof barbs, apertures and/or other structures defined thereon to graspsoft tissue, for example the urethra and/or tissue between the urethraand the bone.

In a preferred embodiment of the invention, the sling is pre-loaded onone or both tacks, before the tacking head is inserted into the body.The pre-loading may be performed in a factory or a work shop, where thesling is produced and/or processed. Alternatively, the pre-loading isperformed at the operating table, possibly after a desired sling lengthis determined

Alternatively, the sling is placed between the tacking head and thebone, inside the body, so that the inserted tack will pass engage thesling before entering the bone. In an exemplary embodiment, one tack ispre-mounted on the sling and is inserted into the bone. The sling isthen stretched using a forceps, for example, and a second tack isinserted through the sling into the bone.

In a preferred embodiment of the invention, only two tacks are used, onefor each side of the sling. Alternatively, more than two tacks may beused for example, for a wide sling (e.g., two tacks on at least on sideof the sling), for an “X” shaped sling or to adjust the length of slingswhich are not tight enough. In some embodiments, one side is tacked andthe other side is sutured or otherwise attached, for example to assistin adjustment. Alternatively, the two ends of the sling may be tackedtogether at a single point on pubic bone 28, possibly using a singletack, thereby forming a closed loop of the sling. Preferably, thatsingle point is not at the center of the pubic bone.

In a preferred embodiment of the invention, a sling is used to supportthe bladder neck. Alternatively, such a sling may be provided to supportthe bladder itself, the urethra and/or other abdominal organs. Bladdersupport, also known as cystocelle repair, generally requires a widesling with a plurality of tacks at each end (or wide tacks). Also, sucha sling may be used to correct a defect in the abdominal floor fromwhich internal organs protrude, by supporting or suspending such organs.Alternatively or additionally, such a sling may be used for malebladder, urethra or bladder neck suspension. Alternatively oradditionally, such a sling may be used for a tongue suspension and/orfor suspending other soft tissues in the body.

In a preferred embodiment of the invention, a catheter is inserted intothe urethra prior to the procedure, to minimize the risk of accidentallypuncturing the urethra. Additionally, such a catheter may be useful whendetermining a desired sling length.

In a preferred embodiment of the invention, a flap-forming incision(e.g., at location 34) is made in the vagina prior to the first tackingor between the first and second tacking, so that the sling can bebrought through the incision, under the flap and into the tissue betweenthe vagina and the urethra. Alternatively, both tacks are tacked (withat least part of the sling still inside the vagina) and then theincision is made in the vagina. In some circumstances, no incision willbe made and a significant portion of the sling will remain in the vagina

Alternatively to making an incision in the vagina, a sub-mucosal tunnelmay be formed in the tissue between the vagina and the urethra and thesling and/or a tacker device (described below) passed through thetunnel. In a preferred embodiment of the invention, only a singleincision is made and the tunnel is made through that incision, forexample using an endoscope. Alternatively, two incisions are made andthe tunnel formed between them. As described herein, such tunnelingpreferably utilizes small incisions in the vagina which are eitherformed by the tacks passing through the vaginal wall to the bone orprepared in advance for the tacks. The tunneling and/or passing may beperformed before the first tacking or between the first tacking and thesecond tacking. When using a tack where the sling is attached to thetack after the tack is inserted into the bone (described below), suchtunneling may even be performed after both tacks are attached to thebone.

In a preferred embodiment of the invention, a small incision and/or holeis made in the vagina for the insertion of each tack. Optionally, tissuewhich intervenes between the vagina and the pubic bone is moved awayfrom the path of the tack so that the tack compresses only a minimalamount of living tissue (other than the sling) against the pubic bone.Alternatively, the tack may create its own hole in the vaginal wall. Asdescribed above, these holes/incisions may be used as an aid to forminga sub-mucosal tunnel which bridges the incisions and is between thevagina and the urethra. In some embodiments of the invention, when atack is tacked to a bone through the hole, a portion of the sling ispulled, by the tack, out of the vagina and into the hole. In anembodiment where only a single incision is made, both tacks (or only asingle one if the tacking is at a single location only) are broughtthrough the same, small, incision.

The tacks are preferably attached to the superior pubis ramus (as shownin the figure). Thus, the sling is angled forward (when the patient isstanding). If the bladder neck or the urethra descend suddenly, the neckis then held up by the sling. Alternatively, the tacks may be attachedto other parts of the pubic bone, for example its bottom or its front,as the tacks may have a flat head which does not cause contactdiscomfort. Additionally or alternatively, especially for bladder necksuspension procedures, it may be desirable to tack the tacks higher upon the bone or even on the abdominal fascia.

In a preferred embodiment of the invention, the length of the sling isdetermined prior to the tacking. Alternatively, after the first tack isinserted, a required sling length may be determined and the sling cut tosize. Optionally, any trailing portions of the sling which remain afterthe tacking are cut off.

FIG. 3 is a schematic illustration of a tack 50 for attaching a sling toa bone, in accordance with a preferred embodiment of the invention. Tack50 includes a sharp tip 52 for entering the bone, a shaft 54 whichgrasps the sling and a head 56 for preventing the sling from slippingoff the shaft and/or for urging the sling against the bone, to preventrelative movement of the sling and the bone. One or more fins 58 may beprovided to improve the bone holding characteristics, however, they dogenerally interfere with insertion into bone. In some embodiments, fins58 are flexible. In other embodiments, they are rigid. Alternatively,other constructions for bone piercing and grasping tips, as known in theart, may be used, for example screw-tipped inserts. In a preferredembodiment of the invention, head 56 comprises a pair of extending arms57. At the tip of each arm (or elsewhere along their length) aprotrusion 59 is preferably provided. As will be shown below, sling 40is preferably urged by protrusions 59 against the bone, however, theentire head may do the urging. Protrusions 59 are preferably flat attheir contact point with sling 40. Alternatively, they may be pointed orroughened. Possibly, holes are formed in sling 40 (prior to, during orafter insertion), so that at least some of the protrusions 59 transfixsling 40 through these holes. Head 56 is preferably flat, however, insome embodiments it may protrude, especially for covering up sharpangles in the head.

In a preferred embodiment of the invention, the arms are perpendicularto the shaft. Alternatively, they may be angled, towards the tip or awayfrom the tip, for example, 10°, 20°, 30° or 45° away from aperpendicular to the shaft. Thus, the tips of the arms can mimic thebehavior of protrusions 59. Preferably the arms are super elastic,however, they can also function correctly if they are elastic, plasticor shape memory. The arms may be in the plane of the shaft or outside ofthe shaft place, possibly not parallel to the shaft plane.

In a preferred embodiment of the invention, a head 56 is wide, forexample a circular plate, a sphere or a half-sphere. In someembodiments, the wide head comprises an expanding head, which, once thetack exits the tacker, expands and/or unfolds to have a wide extent.Preferably, the folded/unexpanded head has a diameter similar to that ofthe shaft, so that the tack is suitable for use in existing anchorinsertion devices. In one example, the unfolding head comprises asuper-elastic material which is maintained at a deformed (small headdiameter) configuration by the tacker. In another example, the expandinghead is expanded as a result of pressures applied during the insertioninto the bone, for example pressure applied by an anvil portion of thetacker which forces the tack into the bone (described below).

One possible disadvantage of the tack of FIG. 3 is that the diameter ofthe shaft is smaller than the diameter of the tip. Thus, when the slingis loaded onto the tack, the tip may rip a larger-than-necessary hole inthe sling. In some cases, the sling is sufficiently flexible and/orelastic to accommodate the tip.

In a preferred embodiment of the invention, it may be desirable toprovide a two part tack, such as tack shown in FIG. 4 as a tack 60, inwhich a head 66 and a shaft 62 form a first portion, having a smalldiameter and on which the sling is skewered. Once the sling is skeweredby shaft 62, a bone engagement portion 64 is mounted on shaft 62, toform a complete tack 60. The end result is thus a tack on which a sling,with only a small hole therethough, is loaded. In some embodiments, head66 is separate from shaft 62. complete tack 60.

Alternatively to using a dedicated tack, a commonly available staple,for example a “U” type staple may also be used to tack the sling to thepubic bone. Thus, the tack may have two or more legs that engage thebone. Possibly however, the quality of the attachment is lower. Forexample, there may be an increased strain on the sling.

Possibly, the sling is not pierced by the tack at all. Rather the slingis provided between the two or more shafts of the tack (or legs of astaple) and is urged against the bone by the head of the tack and heldthereat by friction. Preferably, the portion of the head of the tackthat engages the sling is rough or jagged, to better grasp the sling.Additionally or alternatively, a stop is provided on the one or morelegs, so that a minimal space is provided between the bone and the headof the tack, for example to prevent undue compression of interveningsoft tissue. Additionally or alternatively, the sling may be capturedbetween the shaft and the bone, for example, the shaft has a depressionformed in its side and the sling is held between the depression and theportion of the bone which is inside the hole made by the tack.Alternatively or additionally, the sling may be held by holes in thehead of the tack (described below).

Additionally or alternatively to using a tack, some preferredembodiments of the invention contemplate other methods of attaching thesling directly to the bone, for example using a quick setting adhesive.

In a preferred embodiment of the invention, once the tack is insertedinto the bone, the sling is firmly attached to the bone. In someembodiments of the invention, however, the sling may be fixed to thetack after the tack is attached to the bone. In one example, similar tothat of FIG. 4, a thin-headed tack is attached to the bone and only thenis the sling loaded onto the tack. Thereafter, the head of the tack isattached and/or expanded, to snugly grasp the sling.

In a preferred embodiment of the invention, a guiding wire or suture isattached to the tack, so that the sling can be guided along the guidewire to the tack, for properly engaging it with the tack head. This wiremay then be removed from the tack, as it is does not structurallyinterconnect the tack and the sling. This embodiment is useful forexample if the exact length of the sling is not known in advance.Preferably, the sling has a plurality of holes formed therein, to engagethe shaft of the headless tack at various positions along the sling.

FIG. 5 is a schematic illustration of a tacker 70 for attaching the tack50 of FIG. 3 to pubic bone 28. Tacker 70 preferably comprises a handle72, a body 74, which is preferably curved and adapted for use in thevagina and a head 76, which is urged against the pubic bone forinserting a tack. In this embodiment, a tack 50 is mounted at leastpartially externally to the head. In other embodiments, the tack may bepartially or completely recessed inside head 76. Alternatively oradditionally, a flexible protecting cover is provided, which cover ispushed back from the tip of the tack to the direction of the head of thetack, by the bone when the tack is pressed against the bone. In apreferred embodiment of the invention, a cartridge of such tacks isattached to head 76 or enclosed in body 74.

In a preferred embodiment of the invention, tack 50 is held onto head 76by friction, such that, once it is engaged by the bone it can be removedfrom head 76. Alternatively, a release mechanism (not shown) forpreventing the release of the tack may be provided. Alternatively oradditionally, such a release mechanism may prevent the tops of fins 58from exiting the tacker, so that the tack cannot be irrevocably attachedto the bone, without activating the mechanism. Preferably, force isapplied to the tack by pulling up handle 72, thereby directly pullingback tack 50 into the bone. Alternatively, tacker 70 may include amechanism for advancing tack 50 into the bone, for example a lever basedmechanism or a pneumatic mechanism. In devices with a release or asafety mechanism, the mechanism is preferably released prior to applyingthe force or during the force application, for example by a lever onhandle 72 (not shown).

FIG. 6 is a blow-up of tacking head 76 part of the tacker 70 of FIG. 5.A slot 71 is preferably formed in head 76, to hold arms 57 for the tackconfiguration shown.

FIG. 7 illustrates a tack 50, preloaded on a sling 40 and preloaded onthe tacker, in accordance with a preferred embodiment of the invention.

FIG. 8 is a schematic illustration of a two-headed tacker 80, inaccordance with a preferred embodiment of the invention. Tacker 80includes two arms, an arm 82 and an arm 84, each with a tacking head, 86and 88, respectively. In a preferred embodiment of the invention, thedistance between the tacking heads may be controlled using a screw 90.Screw 90 may set a maximum and/or minimum distance between the tackheads or it may fix the distance between the tack heads. In oneembodiment of the invention, the sling is preloaded on the tacks on thetwo tacking heads, the two heads are placed in the vagina and the twotacks are simultaneously tacked into the pubic bone. An incision forbringing the sling outside the vagina may be made before or after thetacking. Alternatively, the sling is first brought into the desired areabetween the vagina and the urethra, possibly using a tunnel and then thesling is loaded (or not) onto the tacks and the tacks are attached tothe bone.

In a preferred embodiment of the invention, tacker 80 includes only asingle handle 92, which utilizes a single mechanism for advancing bothtacks (if such mechanism is provided). Alternatively, the handleincludes two separate mechanisms. Alternatively, also a second handle 93is provided. Each of handles 92 and 93 may have a separate mechanism.

Alternatively to attaching the tacks substantially simultaneously, thetacker may be used to attach the tacks in series, first one and then theother. Optionally, screw 90 includes a sliding mechanism for allowingonly one of the two handles to be retracted at a time without alsoadvancing the tack of the other handle. In a preferred embodiment of theinvention, setting screw 90 supports fixing the length of the slingoutside the body, by setting the distance between the tacking heads (andthus, typically, the tacks).

FIGS. 9A-9D illustrate an alternative tack 100, in accordance with apreferred embodiment of the invention. FIG. 9A is a perspective view oftack 100, showing a tip 102 of a shaft 104, two fins 108 and a head 106,connected to shaft 104 by crimping an extension 112 of shaft 104 toengage a ring portion 110 of head 106. In a preferred embodiment of theinvention, head 106 comprises two arms 107, having one or more apertures105 formed therein. A protrusion 109, preferably wedge shaped, isprovided at the end of each arm 107.

In a preferred embodiment of the invention, such slings are providedpre-sutured. In a preferred embodiment of the invention, the sutures arein the form of a loop (through which shaft 106 is preferably passed).Such a loop are preferably shortened by knotting, if needed.Alternatively, the sutures are not looped. Such pre-sutured slings mayalso be used for prior art sling procedures.

FIG. 9B is a top view of tack 100.

FIG. 9C is a side view along the direction of line B—B (FIG. 9B) of tack100.

FIG. 9D is a cross-section along line B—B (FIG. 9B) illustrating thecrimping of extension 112 over ring 110. In a preferred embodiment ofthe invention, bead 106 is thus free to rotate relative to shaft 104,however, this freedom is not essential in all embodiments and may evenbe explicitly blocked, for example by forming a notch in ring 110.

FIG. 10, which corresponds to FIG. 6, illustrates the mounting on atacker 120 of tack 100. A slot 122 formed in the head of tacker 120 ispreferably configured so the head fits in apertures 105, by slot 122matching a pair of arms 124 that extend between ring 110 and the rest ofhead 106.

FIGS. 11A-13B illustrate variations in tack designs.

FIG. 11A is a top view of a tack 130 having four arms 132 (rather thantwo). Alternatively, other numbers of arms, for example three may beprovided. Arms 132 are preferably symmetrically arranged and all of asame length, however, this is not essential and in some embodiments onearm may be shorter or two arms may be closer together than the otherarms.

FIG. 11B is a cross-sectional view of a tack 140, corresponding to FIG.9D and showing an alternative method of attaching a head 142 to a shaft144, for any type of tack, in which a slot 146 is formed in shaft 144,to receive head 142. An advantage of this method is that an incorrectlyplaced tack may be corrected by removing the head and advancing theshaft so it is completely enclosed by the bone. In a preferredembodiment of the invention, the head is super-elastic or elastic, sothat by applying enough force it can be mounted on the shaft or removed,without permanently distorting it. Alternatively, one time elastic orplastic heads are used, alternatively, a shape-memory material may beused.

FIGS. 12A-12C illustrates variations of head portions of tacks. FIG. 12Aillustrates ahead 150 which defines a plurality of apertures 152 thereinand has a plurality of protrusions 156 around its perimeter (and alsopossibly inside the perimeter), which protrude towards the bone. Centralaperture 154 is preferably used to affix head 150 to a shaft of a tack.The apertures may or may not be aligned with the protrusions that mostforcefully engage the sling.

FIG. 12B illustrates, in top view, a tack 160, which comprises spiralarms 162, rather than straight arms as described above. An advantage ofspiral arms is an increased flexibility of the arms, withoutcompromising their strength. A pair of fins 164 are also shown, forexample of the type used in device 100 of FIG. 9.

FIG. 12C illustrates, in top view, a tack 170, which has only a singlearm 174. A pair of fins 174 is also shown, perpendicular to the arm.Alternatively, the fins are parallel or oblique to the arm.Alternatively, only one fin 174, preferably opposite arm 172, is used.

FIGS. 13A and 13B illustrate a recessed fin tack 180, in accordance witha preferred embodiment of the invention. Tack 180 comprises a head 190attached to a shaft 182 with a tip 184. At least one fin 186, butpossibly more than one, extend from shaft 182, as shown in FIG. 13A. Ina preferred embodiment of the invention, a recess 188 is formed in shaft182, to receive fin 182 during insertion into the bone, so fin 186 doesnot impede the insertion process (FIG. 13B). Preferably, duringinsertion, the edge of the bone presses fin 182 into recess 188. In apreferred embodiment of the invention, shaft 182 or fin 186 is formed ofan elastic, shape-memory or super-elastic material, to assure that fin186 returns to an extended configuration as shown in FIG. 13A.

FIGS. 13C and 13D illustrate an expanding head tack 200, in accordancewith a preferred embodiment of the invention. Tack 200 comprises a shaft202, preferably with a plurality of fins 206 at its tips. The head oftack 200 comprises two distortable parts 210. As shown, two or moreseparate arms are provided, possibly each one with a protrusion as insome of the previous embodiments. Alternatively, an extension of shaft202 may be split. When the tack is inserted the head may be narrow, asshown in FIG. 13C. When the tack is inserted into a bone, the head issplit, for example using a cone shaped element 212, resulting in a tackas shown in FIG. 13D, which can be substantially the same as the tack ofFIG. 3. In a preferred embodiment of the invention, an advance-stop 208is provided, to prevent shaft 202 from advancing too far, especiallywhile portions 210 are being split apart. Such a stop may also beprovided in other tack design, for example to provide a minimum distancebetween the head and the bone. Alternatively, the advance stop is partof the tacking head, for example being in the form of forceps or a “C”shaped element which space the head from the bone and is removed withthe tacking head. Possibly, the advance stop is formed of anbio-absorbable material.

In a preferred embodiment of the invention, advance-stop 208 extendsaway from shaft 202, at least in one transaxial direction, more thanportions 210 in their unexpanded configuration. In a preferredembodiment of the invention, a slotted insertion device pushes againstadvance-stop 208 and an additional internal mandrel is provided to serveas element 212. Thus, portions 210 are distorted plastically.Alternatively, the portions may be formed of a shape-memory material(which can be optionally heated by the tacking head). Alternatively, theportions may be elastic or super-elastic. Preferably, the portions aremaintained in their narrow configuration by the slotting head, which,when removed, allow them to snap open to their wide configuration.Alternatively or additionally, a bi-stable or a bimetal-mechanism forconfiguration change may be used. Such elastic, plastic, shape-memory,super-elastic or other head distorting mechanism may be used with any ofthe tack-heads described above.

Additional variations in tack design are also contemplated in accordancewith preferred embodiments of the invention. For example, the shaft ofthe tack may have a fixed or a varying profile, which can be, forexample, circular, square, rectangular, triangular, fluted and/orspiral. Also, the shaft may be barbed and/or roughened. The tip of thetack may be, for example, smooth, fluted, threaded, spiral, inclined onsome sides and flat on the others. Alternatively or additionally, thetip may be oblique, for example as shown in FIG. 13. The fins may be,for example, of a design that is rigid or that folds back towards theshaft during insertion. The arms of the head may be, for example,perpendicular to the shaft or they may be slanted. Possibly, the armconfiguration is designed to match a anatomical geometry, such as a boneincline. The fins may be distributed with a rotational symmetry aroundthe shaft axis. Alternatively, they are not. Alternatively oradditionally, the fins are all at a same axial position along the shaft.In some embodiments, they are not.

FIG. 14 is a schematic illustration of a sling grasping attachment 904for a stapler 900, in accordance with a preferred embodiment of theinvention. As described above, in some cases, even a standard typestaple, bone anchor and/or bone screw may be used to attach sling 40directly to the bone. Such screws and staples usually include a stop forlimiting the penetration depth into the bone, which can serve as a tack“head”, in accordance with a preferred embodiment of the invention. Theportion of a shaft behind the stop, including for example a threadablehole, may be filed off, especially if they are not required for thestructural integrity of the bone insert. However, the standardizedstaplers, anchor insertion devices and other bone attachment apparatusdo not appear to provide for a sling that is engaged by the staple.Attachment 904, is an example of an attachment which maintains the slingin a desired position and/or orientation relative to the staple, untilthe staple is inserted into the bone. In this embodiment, attachment 904comprises a resilient clip that urges and holds the sling against thebody of stapler 900. In other embodiments, the attachment may be mountedover the tacking head, possibly extending the head length. In somecases, for example as shown, a staple 906 may pierce the sling, prior tothe act of stapling. In other cases, the tip of the staple is recessedin the stapler and cannot engage the sling. In other embodiments of theinvention, other attachments may be provided. In particular, the exactgeometry of the attachment may be adapted for a particular stapler modeland/or staple type.

In a preferred embodiment of the invention, the above described slingsand tacks are provided as a kit which includes one or more slings ofpossibly varying lengths and two or more tacks.

Although the above description has focused on female urinaryincontinence, a same procedure and apparatus may be used for maleincontinence, for example, by attaching the sling to a descending ramousof the pubic bone through an incision in the perineal area.

It will be appreciated that the above described apparatus and methods ofincontinence treatment may be varied in many ways. In addition, amultiplicity of various features, both of methods and of devices, havebeen described. It should be appreciated that different features may becombined in different ways. In particular, not all the features shownabove in a particular embodiment are necessary in every similarpreferred embodiment of the invention. Further, combinations of theabove features are also considered to be within the scope of somepreferred embodiments of the invention. It should also be appreciatedthat many of the embodiments are described only as methods or only asapparatus. The scope of the invention also covers machines for creatingthe devices. In addition, the scope of the invention includes methods ofusing, constructing, calibrating and/or maintaining the apparatusdescribed herein. When used in the following claims, the terms“comprises”, “comprising”, “includes”, “including” or the like means“including but not limited to”.

What is claimed is:
 1. A method of preparing a sling combination fortreating incontinence, comprising: providing a sling for placementunderneath a patient's urethra to support the urethra, the sling beingformed of a biocompatible material and having a body comprising twoends; mounting said sling on a first tack at a first end of the body ofthe sling; and mounting said first tack on a tacking device.
 2. A methodaccording to claim 1, comprising mounting said sling on a second tack ata second end of the body of said sling.
 3. A method according to claim2, comprising mounting said second tack on said tacking device.
 4. Amethod according to claim 1, comprising adjusting an offset between twotacking heads of said tacking device.
 5. A method according to claim 1,comprising cutting said sling to size after mounting said first tack onsaid sling.
 6. A method according to claim 1, wherein mounting saidsling on said first tack is performed after said tack is mounted on saidtacking device.
 7. A method according claim 1, comprising assemblingsaid first tack after mounting said sling on said first tack.
 8. Amethod according to claim 7, wherein assembling said first tackcomprises attaching at least one fin to a shaft of said tack.
 9. Amethod according to claim 1, comprising assembling said first tack aftermounting said first tack on said tacking device.
 10. A method accordingto claim 1, wherein mounting said sling on said tack comprises piercingsaid sling by said tack.
 11. A method according to claim 1, comprisinginserting at least a part of said tacking device into a human vagina,after mounting said tack on the tacking device.
 12. A method ofpreparing a sling combination, comprising: providing a sling formed of abiocompatible material and having a body comprising two ends; mountingsaid sling on a first tack at a first end of the body of the sling;mounting said first tack on a tacking device, and wherein mounting saidsling on said first tack is performed before said tack is mounted onsaid tacking device.
 13. A method of preparing a sling combination,comprising: providing a sling formed of a biocompatible material andhaving a body comprising two ends; mounting said sling on a first tackat a first end of the body of the sling; mounting said first tack on atacking device, assembling said first tack after mounting said sling onsaid first tack, and wherein assembling said first tack comprisesattaching a head to a shaft of said tack.
 14. A method of preparing asling combination, comprising: providing a sling formed of abiocompatible material and having a body comprising two ends; mountingsaid sling on a first tack at a first end of the body of the sling;mounting said first tack on a tacking device, and wherein mounting saidsling on said tack comprises inserting said tack into a hole in saidsling.
 15. A method of preparing a sling combination for treatingincontinence, comprising: providing a sling for placement underneath apatient's bladder neck to support the bladder neck, the sling beingformed of a biocompatible material and having a body comprising twoends; mounting said sling on a first tack at a first end of the body ofthe sling; and mounting said first tack on a tacking device.